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Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

Comprehensive comparative effectiveness and safety of first-line antihypertensive drug classes: a systematic, multinational, large-scale analysis
Publication date: Available online 24 October 2019Source: The LancetAuthor(s): Marc A Suchard, Martijn J Schuemie, Harlan M Krumholz, Seng Chan You, RuiJun Chen, Nicole Pratt, Christian G Reich, Jon Duke, David Madigan, George Hripcsak, Patrick B RyanSummaryBackgroundUncertainty remains about the optimal monotherapy for hypertension, with current guidelines recommending any primary agent among the first-line drug classes thiazide or thiazide-like diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, dihydropyridine calcium channel blockers, and non-dihydropyridine calcium channel blockers, in ...
Source: The Lancet - October 26, 2019 Category: General Medicine Source Type: research

Incidence of neurodegenerative and cerebrovascular diseases associated with antihypertensive drug classes.
Authors: Harrison PJ, Colbourne L, Luciano S Abstract Antihypertensive drugs (AHTs) are associated with lowered risks of neurodegenerative diseases and stroke. However, the relative risks associated with different AHT classes are unclear. Using an electronic health record network with 34 million eligible patients, we compared rates of these disorders over a 2-year period, in propensity score-matched cohorts of people taking calcium channel blockers (CCBs) compared with those taking other AHT classes. CCBs were associated with a higher incidence of all disorders compared with renin-angiotensin system agents, and a h...
Source: The British Journal of Psychiatry for Mental Science - January 9, 2021 Category: Psychiatry Tags: Br J Psychiatry Source Type: research

Risk of cardiovascular events in patients having had acute calcium pyrophosphate crystal arthritis
Conclusions Acute CPP crystal arthritis was significantly associated with elevated short and long-term risk for non-fatal CV event.
Source: Annals of the Rheumatic Diseases - August 11, 2022 Category: Rheumatology Authors: Tedeschi, S. K., Huang, W., Yoshida, K., Solomon, D. H. Tags: ARD, Crystal arthropathies Source Type: research